Alison Tew
- Role
- Product Quality Release Manager at Sanofi
- Location
- Newburgh, NY, US
- LinkedIn followers
- 500 followers
About Alison Tew
Quality Assurance (Manufacturing)- cGMP Quality driven Qualified Quality Assurance…
Experience
Product Quality Release Manager
Oct 2020 — Present
Protein Sciences | A Sanofi Company Vaccines Quality Assurance Raw materials and Finished Bulk oversight Batch Record Review- Bulk and Finished goods Logistics Change Control Facility - Environmental controls Investigations SOPs and approvals Preparations of COAs, COCs for Bulk and Finished goods Applications: Geode, Phenix, LIMS, SharePoint, Opstrakker
Skills
- Dissolution
- Technology Transfer
- R&D
- Fda Gmp
- Gcp
- Capa
- Medical Devices
- Regulatory Requirements
- Gmp
- Validation
- Fda
- Quality Management
- Manufacturing
- Deviations
- Gxp
- Chemistry
- Quality Assurance
- Clinical Development
- Root Cause Analysis
- Regulatory Affairs
- Hplc
- 21 Cfr Part 11
- Lifesciences
- V&V
- Process Improvement
- Clinical Trials
- Glp
- Quality Auditing
- Quality System
- Cleaning Validation
- Iso 13485
- Usp
- Regulatory Submissions
- Quality Control
- Aseptic Processing
- Vaccines
- Biotechnology
- Sop
- Software Documentation
- Pharmaceutical Industry
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